BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1861320 · Received October 4, 2010

    Report

    Report Number
    2531779-2010-01404
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. DURING EVAL, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. EVIDENCE OF MOISTURE WAS FOUND ON THE FORCE SENSOR ASSEMBLY. EVAL ALSO REVEALED A MISALIGNED DISPLAY SCREEN. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING.

    Description of Event or Problem · 1

    DURING EVAL, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR